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Generated: September 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201675

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NDA 201675 describes ESTRADIOL, which is a drug marketed by Mayne Pharma, Mylan, Lannett Holdings Inc, Ortho Mcneil Pharm, Amneal Pharms, Mylan Technologies, Epic Pharma Inc, Teva Pharms Usa, Barr Labs Inc, Usl Pharma, Breckenridge Pharm, Mylan Labs Ltd, Barr, Watson Labs, Luitpold, Sandoz Inc, and Watson Labs Inc, and is included in twenty-two NDAs. It is available from thirty-one suppliers. Additional details are available on the ESTRADIOL profile page.

The generic ingredient in ESTRADIOL is estradiol valerate. There are seventy-five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the estradiol valerate profile page.

Summary for NDA: 201675

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 201675

Ingredient-typeEstradiol Congeners
Mechanism of ActionEstrogen Receptor Agonists

Suppliers and Packaging for NDA: 201675

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESTRADIOL
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL 201675 ANDA Mylan Pharmaceuticals Inc. 0378-4640 0378-4640-26 8 POUCH in 1 CARTON (0378-4640-26) > 1 PATCH in 1 POUCH (0378-4640-16) > 3.5 d in 1 PATCH
ESTRADIOL
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL 201675 ANDA Mylan Pharmaceuticals Inc. 0378-4641 0378-4641-26 8 POUCH in 1 CARTON (0378-4641-26) > 1 PATCH in 1 POUCH (0378-4641-16) > 3.5 d in 1 PATCH

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.025MG/24HR
Approval Date:Dec 19, 2014TE:AB1RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.0375MG/24HR
Approval Date:Dec 19, 2014TE:AB1RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.05MG/24HR
Approval Date:Dec 19, 2014TE:AB1RLD:No


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Serving 500+ biopharmaceutical companies globally:

Cerilliant
McKesson
AstraZeneca
UBS
Citi
Fuji
Farmers Insurance
Queensland Health
Daiichi Sankyo
Harvard Business School

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